I and others have attributed much of the initially flat‐footed response of public health officials to the coronavirus pandemic to cumbersome, inflexible, and outdated regulations controlling the development and distribution of drugs and tests.
As I pointed out in an article earlier this week, while the cumbersome Food and Drug Administration’s approval process delayed the development and distribution of coronavirus tests in the U.S. in the early days of the current pandemic, South Korea, having learned from its horrible encounter with the Middle East Respiratory Syndrome (MERS) outbreak of 2015, enacted regulatory reforms that allowed the government to give almost immediate approval of testing systems developed during a public health emergency.
In recent days the FDA has relaxed its regulatory process in order to get tests out to the public more rapidly. On March 13 Roche labs received expedited approval to distribute a test it developed that yields results ten times faster than the CDC‐developed test. On March 16, perhaps in an attempt to replicate the South Korean model, the FDA exercised its regulatory authority to effectively outsource the approval process to the states. The FDA delegated to states the authority to oversee and approve tests developed within their borders. It also announced that, under certain circumstances, manufacturers may distribute newly developed tests before the FDA grants emergency use authorization, and labs will be permitted to use them.
As a result of these measures, Indiana‐based pharmaceutical manufacturer Eli Lilly and Co. announced on March 18 it will be performing tests on samples taken in health care facilities within the state of Indiana–including nursing homes and emergency rooms–free of charge to patients, insurers, hospitals, and government agencies. A company spokesman said it could be performing 1,000 tests per day within a week and hopes to ramp the number up to 2,000 per week by using a drive‐thru clinic. Tests results should be back the same day. Indiana State Health Commissioner Kris Box praised this “public‐private partnership.”
The speed with which the private sector is responding to the demand for coronavirus testing once the regulatory ankle weights have been temporarily removed is a spectacle that should not go unnoticed by politicians and policymakers. It is unfortunate that it took a calamitous epidemic to provide this lesson in deregulation. Let’s hope the lesson is taken to heart and leads to permanent regulatory reform when the crisis passes.